🔗 Share this article

While the United States proceeds with unprecedented revisions to its immunization recommendations, a particular individual has surfaced somewhat surprisingly: Høeg, a Danish American sports medicine doctor and epidemiologist who initially gained attention by casting doubt on COVID-19 vaccinations throughout the pandemic and has zeroed in on possible fatalities following COVID-19 vaccination in her recent time at the US Food and Drug Administration (FDA).

Proposed Shifts to Childhood Vaccine Program

Agency leaders were set to reveal radical revisions to the childhood immunization program in December, bringing the US with Denmark’s national calendar, it is understood – a major change that would put the US out of alignment with much of the international standard with insufficient data for improved outcomes. The planned update has been pushed back until the coming year.

In place of Vinay Prasad, Dr. Høeg is scheduled to address the audience at the event. She was newly appointed acting director of the FDA’s CDER, the fifth person to lead the office this calendar year.

A Shift at the Regulatory Body

The acting appointment might represent a closer partnership between the pharmaceutical and biologics divisions as Dr. Høeg and Prasad solidify control at the FDA – and it signals a renewed priority upon reevaluating already-approved immunizations at the FDA.

The new acting director has repeatedly called for ending some childhood shot schedules in the US so as to align more similar to Denmark, a nation with universal health coverage and a citizenry roughly the population of the state of Wisconsin.

So far statements, she has persisted in emphasizing on immunizations – typically the domain of Prasad, head of the FDA’s vaccine center – rather than pharmaceutical oversight.

Doubts Over Background

Høeg has no obvious background in pharmaceutical research, oversight or management, which has been standard for former heads of the CBER. She has worked at the FDA as a top consultant to the commissioner and CBER since spring.

“She doesn’t seem to have any of the qualifications” for leading the drug-regulation department, remarked a neurologist and psychiatrist. “She has not conducted a clinical trial. She lacks experience in leading a major agency. She has no expertise in industry regulation.”

Previous heads of CBER would “be deeply familiar with regulatory frameworks and the underlying principles of drug development”, noted a former acting FDA commissioner. “Frankly, she has not acquired the type of experience that prior appointees who ran CBER have had.”

The drug center has an vast range of responsibilities at the agency, the former commissioner stated.

“Everybody just focuses on the novel medication approvals, but the generic program authorizes thousands of generic drugs. There is also a biosimilars division, OTC medication office and more, and all of those need to be managed,” she explained. “The thing you don’t keep your eye on, that’s the thing that I always told people is going to cause problems.”

There is also, a substantial management component to the role, which oversees over 5,000 staff members. “It is a enormous leadership role, if you do it right,” the former official concluded.

Agency Reaction and Disputed Policies

Regarding questions about Dr. Høeg's qualifications and whether this selection represents increased cooperation among regulatory chiefs on immunizations, a representative stated that the “concerns are based on incorrect assumptions”.

“Her experience is consistent with the responsibilities of her position,” the spokesperson said, citing the period Høeg spent counseling the FDA commissioner on “pharmaceutical safety and oversight research, including computational safety modeling and vaccine surveillance”.

As the temporary head, Høeg assumes responsibility for the commissioner’s recently launched fast-track approval initiative, a contentious one-day therapy clearance system that reportedly concerned her predecessors. “How are these therapies being chosen for this fast-track system? Who makes the choices?” Dr. Howard said. “There is a lot of lack of transparency happening at the agency right now.”

Overall, he remarked, “the Food and Drug Administration appears to be shifting towards less stringent rules of all drugs, except for immunizations.”

Documented History on Immunizations

With vaccines, Høeg has a more documented, if problematic, track record, Howard observe. She published a research paper using unverified crowd-sourced reports to assess the rate of myocarditis after Covid immunization. She advised the state of Florida chief medical officer Dr. Joseph Ladapo, who was said to have modified findings to imply Covid vaccines are pose a greater threat than they are.

Part of her “policy goals” for the new government featured revising guidelines for new vaccines and halting “non-essential” vaccines, she said after the election on a online show. At the agency, Dr. Høeg has reportedly floated the idea of barring teenage boys from receiving COVID-19 vaccinations.

“She is an complete ideologue who begins with her conclusions and tailors the evidence to retrofit the data in a highly misleading, fraudulent fashion,” Howard argued.

Taking Control and a “Revenge Tour”

Dr. Høeg became part of fellow skeptics, {like|